Allarity Therapeutics, Inc. announced the publication of its clinical validation of a novel drug-specific DRP®-companion diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients. PLOS ONE published the paper online today titled, ?A novel drug-specific mRNA biomarker predictor for selection of patients responding to dovitinib treatment of advanced renal cell carcinoma and other solid tumors.?

Dovitinib is a pan-targeted kinase inhibitor (pan-TKI) formerly developed through Phase 3 clinical studies. The DRP®-Dovitinib CDx is a complex transcriptomic signature comprising 58 mRNA biomarkers that are collectively predictive of tumor response to the drug.   In the study evaluating pre-treatment biopsies of 135 advanced RCC patients, the DRP® positive subgroup (indicating that the patient was likely to respond) (N=49) had a median overall survival of 15 months (96% CI 12.94-26.25), whereas the DRP® negative subgroup (N=86) had a median overall survival of 9.13 months (95% CI 7.49-13.2). The hazard ratio was 0.60 (95% CI 0.39-0.91).

In addition to the 135 RCC biopsies, the DRP®-Dovitinib showed equally promising data in a number of other solid tumors, such as hepatocellular carcinoma (HCC), thereby demonstrating that it is independent of tumor type and has applicability beyond RCC. Dovitinib has been the focus of numerous clinical studies, showing promising properties as an anti-cancer agent, but is not yet approved for the treatment of any cancer type. It is currently being advanced by Allarity in [3] an ongoing Phase 1b clinical study [4] exploring the potential synergy of dovitinib and stenoparib (a PARP inhibitor) for the treatment of advanced solid tumors, including ovarian cancer.

In addition, in partnership with Allarity [5], Oncoheroes Biosciences has an ongoing program to develop dovitinib, together with the DRP®-dovitinib CDx, as a treatment for pediatric osteosarcoma.